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Treatment of Disseminated High Grade Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536393
First Posted: September 27, 2007
Last Update Posted: November 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
French Innovative Leukemia Organisation
  Purpose
Interest of the use of pegylated liposomal doxorubicin (caélyx)

Condition Intervention Phase
Lymphoma Drug: Doxorubicin Drug: Doxorubicin pegylated Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)

Resource links provided by NLM:


Further study details as provided by French Innovative Leukemia Organisation:

Primary Outcome Measures:
  • hematologic toxicity [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 6 months ]
  • EFS and OS [ Time Frame: 6 months ]
  • Cardiac toxicity [ Time Frame: 6 months ]

Enrollment: 100
Study Start Date: October 2000
Study Completion Date: October 2004
Arms Assigned Interventions
Active Comparator: Doxorubicine
CHOP 8 courses every 21 days
Drug: Doxorubicin
Experimental: Doxorubicine pegylated
CLOP 8 courses every 21 days
Drug: Doxorubicin pegylated

Detailed Description:
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high grade lymphoma
  • disseminated
  • > 60 years old and < 75
  • informed consent signed
  • cardiac state compatible with antracyclin
  • ECOG </= 2

Exclusion Criteria:

  • patients > 75 years old
  • Cardiac insufficiency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536393


Locations
France
Clinique Victor Hugo
Le Mans, France, 72015
Sponsors and Collaborators
French Innovative Leukemia Organisation
Investigators
Principal Investigator: Guillaume CARTRON, Dr French Innovative Leukemia Organisation
  More Information

ClinicalTrials.gov Identifier: NCT00536393     History of Changes
Other Study ID Numbers: GOELAMS 0804
First Submitted: September 26, 2007
First Posted: September 27, 2007
Last Update Posted: November 1, 2007
Last Verified: September 2007

Keywords provided by French Innovative Leukemia Organisation:
diffuse larg cells lymphoma
chemotherapy
toxicity
diffuse high grade lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action